Three BIG FDA Tech Approvals

There were three big diabetes technology announcements during the American Diabetes Association 78th Scientific Sessions this week. It seems that advances and approvals are coming at a quick pace.

Make sure to visit Diabetes Daily as we continue to give updates from the ADA Scientific Sessions.

Eversense Impantable Continuous Glucose Monitor (CGM)

Highlights:

Continuous glucose monitor

Approved for ages 18 and older

90-day wear

Implantable by healthcare providers

From the press release: “The U.S. Food and Drug Administration today approved the Eversense Continuous Glucose Monitoring (CGM) system for use in people 18 years of age and older with diabetes. This is the first FDA-approved CGM system to include a fully implantable sensor to detect glucose, which can be worn for up to 90 days.”

From the press release: “Tandem’s Basal-IQ algorithm is designed to look 30 minutes into the future to predict where glucose levels are heading. The device suspends insulin delivery when low glucose is predicted, then automatically resumes insulin delivery once glucose levels begin to rise. Use of the t:slim X2 Pump with Basal-IQ technology in the pivotal clinical study demonstrated a 31 percent relative reduction in time spent below 70 mg/dL, with no rebound hyperglycemia compared to a CGM-enabled insulin pump without the feature.”

Medtronic MiniMed 670G Pediatric Indication

Highlights:

Approval for ages 7-13 years of age

Hybrid closed loop system

SmartGuard automated insulin delivery

Insulin pump and continuous glucose monitor (CGM)

From the press release: “FDA approval was based on positive results from a pediatric clinical trial, which demonstrated the safety of the MiniMed 670G system in this younger patient population. Data was analyzed from 105 children between seven and 13 years of age with type 1 diabetes during a two-week baseline period in open-loop mode (traditional pump therapy), followed by a three-month in-home study period with the hybrid-closed loop (SmartGuard Auto Mode) enabled. The results showed the percentage of Time in Range increased from 56.2 percent to 65.0 percent. A1C levels were also reduced from 7.9 percent to 7.5 percent. There were no incidences of diabetic ketoacidosis (DKA) in the study phase in Auto Mode and no severe hypoglycemic or serious device-related adverse events were reported. Almost all children continued to use the pump after the study concluded. ”

When Leighann Calentine’s daughter Q was diagnosed with type 1 diabetes in 2008 at the age of three, she began sharing their story on her “mommy blog,” eventually launching D-Mom Blog to help other parents of children with diabetes. Leighann says that like others dealing with diabetes, she and her husband count carbs, carry juice boxes, and are always on call. In her book Kids First, Diabetes Second, she shares how they manage their daughter’s diabetes, first with injections and now with an insulin pump, navigate playing several sports, and tackle sending her to public school, all while making sure that Q is a child first and that diabetes is second.

Comments

Boy, the Tandem announcement is a surprise, I was talking with the Tandem folks yesterday asking them about the integration of the Dexcom G6 with the Tandem pump. They told me that the predictive software would first be introduced using then G5 and later in the year the G6 would be integrated.